A Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults

NCT05892627 | Unknown Early Phase 1

• 1 other identifier: 23766
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

PoZibio™ capsules contains Lactobacillus paracasei which has been heat-killed (post-biotic). The researchers will recruit a cohort of middle aged and older adults (\>50 years) who will be randomised into PoZibio™ (2 x capsules daily) or placebo (2 x capsules daily) supplementation for 6 weeks. Subjects will be asked to take both capsules in the morning with their breakfast. The placebo will be matched to the active product by taste and texture. Electroencephalography (EEG) shall be combined with 3 psychological tasks, to measure a variety of cognitive domains including attention, processing speed, accuracy, and response inhibition. These psychological tasks shall include the Stroop task, the Go/No-go task, and the Flanker task. Before taking part in the psychological tasks, participants shall be required to have their EEG resting state recorded, requiring them to participate in an Eyes Open/Closed Task. The Mini Mental State Exam (MMSE) questionnaire shall be used as a digital screening tool to assess global cognitive function in participants both prior to and following the 6-week PoZibio trial. The geriatric depression scale (GDS) shall also be used as a digital screening tool to assess for depressive symptomatology in older adults. The EQ-5D questionnaire shall be used to obtain an overall profile of the health state and quality of life of participants before and after the trial. The researchers will collect venous blood samples for the investigation into the chemical composition using metabolomics, the quantification of short chain fatty acids as well as clinical biochemistry, before and after the trial. Aim: A randomised, placebo controlled parallel human clinical trial of heat-treated Lactobacillus paracasei (post-biotics) in healthy middle aged and older subjects is proposed, to assess the potential for clinically relevant benefits in terms of cognitive function.

Conditions

Cognitive Decline

Keywords

Electroencephalography; Post-biotic; Lactobacillus paracasei; Cognitive health; Mental function; Metabolomics

Outcome Measures

Primary Outcomes (20)

• Cognitive Control (Selective attention, processing speed, mental flexibility)

  Cognitive Control (Selective attention, processing speed, mental flexibility) measured using the Stroop task in E-Prime

  Improved score (faster response time and improved accuracy) from baseline score at 6 weeks after pozibio

• Cognitive Control (Selective attention, processing speed, mental flexibility)

  Cognitive Control (Selective attention, processing speed, mental flexibility) measured using the Stroop task in E-Prime

  Improved score (faster response time and improved accuracy) at 6 weeks after pozibio when compared with placebo after 6 weeks

• Response inhibition (core construct in cognitive control and self-regulation)

  Measured using the Go/No-go task in E-Prime

  Improved (fewer commission errors) score from baseline score at 6 weeks after pozibio

• Response inhibition (core construct in cognitive control and self-regulation)

  Response inhibition (core construct in cognitive control and self-regulation) measured using the Go/No-go task in E-Prime

  Improved (fewer commission errors ) score at 6 weeks after pozibio when compared with placebo after 6 weeks

• Selective attention and response inhibition (core constructs in cognitive control and self-regulation)

  Selective attention and response inhibition (core constructs in cognitive control and self-regulation) measured using the Flanker task in E-Prime

  Improved score (faster response time and improved accuracy) from baseline score at 6 weeks after pozibio

• Selective attention and response inhibition (core constructs in cognitive control and self-regulation)

  Selective attention and response inhibition (core constructs in cognitive control and self-regulation) measured using the Flanker task in E-Prime

  Improved score (faster response time and improved accuracy) at 6 weeks after pozibio when compared with placebo after 6 weeks

• Electroencephalogram (EEG) during the Stroop task

  Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions

  After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with baseline

• Electroencephalogram (EEG) during the Stroop task

  Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions

  After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with 6 weeks of placebo

• Electroencephalogram (EEG) during the Flanker task

  Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions

  After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with baseline

• Electroencephalogram (EEG) during the Flanker task

  Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions

  After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with 6 weeks of placebo

• Electroencephalogram (EEG) during the go/no-go task

  Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions

  After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with baseline

• Electroencephalogram (EEG) during the go/no-go task

  Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions

  After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with 6 weeks of placebo

• Electroencephalogram (EEG) during the stroop task

  Assessing alpha and delta activity

  After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline

• Electroencephalogram (EEG) during the Flanker task

  Assessing alpha and delta activity

  After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline

• Electroencephalogram (EEG) during the go/no-go task

  Assessing alpha and delta activity

  After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline

• Electroencephalogram (EEG) during the stroop task

  Assessing alpha and delta activity

  After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo

• Electroencephalogram (EEG) during the Flanker task

  Assessing alpha and delta activity

  After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo

• Electroencephalogram (EEG) during the go/no-go task

  Assessing alpha and delta activity

  After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo

• EuroQol 5 Dimension 5L (combined score)

  EuroQol 5 Dimension 5 5L questionnaire: Generic quality of life. Mobility- Level 1-5 Self-Care- Level 1-5, Usual Activities- Level 1-5, Pain/Discomfort- Level 1-5, Anxiety/Depression- Level 1-5. The digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state.

  Reduced score from baseline EuroQol 5 Dimension 5 score at 6 weeks after pozibio

• EuroQol 5 Dimension 5L (combined score)

  EuroQol 5 Dimension 5 5L questionnaire: Generic quality of life. Mobility- Level 1-5 Self-Care- Level 1-5, Usual Activities- Level 1-5, Pain/Discomfort- Level 1-5, Anxiety/Depression- Level 1-5. The digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state.

  Reduced EuroQol 5 Dimension 5 score at 6 weeks after pozibio when compared with placebo after 6 weeks

Secondary Outcomes (2)

• Changes in short chain fatty acids concentrations in plasma

  Increased concentration of total short chain fatty acids after the pozibio at 6 weeks compared with the baseline

• Changes in short chain fatty acids concentrations in plasma

  Increased concentration of total short chain fatty acids after the pozibio at 6 weeks compared with that after placebo at 6 weeks

Study Arms (2)

PoZibio

EXPERIMENTAL

PoZibio, twice daily (50 x 10\^9 CFUs/ CAPSULE) for 6 weeks

Dietary Supplement: PoZibio

Placebo

PLACEBO COMPARATOR

Placebo, twice daily for 6 weeks

Dietary Supplement: Placebo

Interventions

PoZibio DIETARY_SUPPLEMENT

PoZibio (50 x 10\^9 CFUs/ CAPSULE)

PoZibio

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects over 50 years of age
• Subjects with Mini-Mental State Exam (MMSE) of 25-30 inclusive (global cognitive function)
• Subjects who are able to undergo EEG and to commit to visits to WARU/P5.
• Subjects who are able to provide venous blood samples.
• Subjects able to provide written informed consent PRIOR to performing any study procedures.

You may not qualify if:

• Subjects with diagnosis of Alzheimer's disease or other dementia
• Subjects taking medication for the treatment of dementia (such as acetylcholinesterase inhibitors (Aricept, Excelon), memantine (Namenda) or other medications with similar mechanisms of action) or medical foods (such as Cerefolin, Souvenaid, Axona) for the treatment of dementia.
• Subjects who are already regularly taking probiotics, post-biotics, nutraceutical and/or vitamin supplements related to PoZibio ™ within 30 days of screening.
• Subjects with Geriatric Depression Scale \> 6
• Subjects with a Mini Mental State Exam score below 25
• Subjects who are pregnant or lactating
• Subjects with medical condition or disease that is life threatening
• Subjects who smoke cigarettes or use other products containing nicotine.
• Subjects diagnosed with diabetes.
• Subjects taking warfarin.
• Subjects who identify as being vegetarian or vegan
• Subjects who have a diagnosed or suspected mental health condition, or who have any concerns surrounding their mental health
• Subjects who have immediate family members with diagnosed mental health condition or suspected mental health concerns

Sponsors & Collaborators

• Aberystwyth University: lead
• AGROCEUTICAL PRODUCTS LTD: collaborator
• Neurodyn Life Sciences Inc.: collaborator
• Postbiotics Inc: collaborator
• Welsh Government: collaborator

Study Sites (1)

Well-being and Health Assessment Research Unit (WARU)

Aberystwyth, Ceredigion, SY23 3FD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Amanda J Lloyd, PhD, BSc

  Aberystwyth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda J Lloyd, PhD, BSc

CONTACT

07811618109; abl@aber.ac.uk

Alina Warren, Ms, BSc

CONTACT

07539440811; arw21@aber.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cohort who will be randomised into PoZibio™ (2 x capsules daily) or placebo (2 x capsules daily) supplementation for 6 weeks.

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: June 7, 2023
• Study Start: June 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)